How FDA Can Respond To Inspections
The Form 483 lists observations made by the FDA representative(s) during the inspection
If the inspection does not yield any objectionable conditions or practices, a 483 will not be issued.
However, if the FDA representative(s) does observe objectionable conditions, one or more 483 will be issued during the closing meeting.
Depending the nature of the violation(s), the FDA may give the firm an opportunity to take voluntary and prompt action to correct the violation(s) before the agency initiates an enforcement action.
The FDA uses untitled letters for violations that are not as significant as those that prompt warning letters.
Warning letters, on the other hand, are issued to manufacturers or other organizations that have violated some rule in a federally regulated activity.
Injunctions may also be ordered to halt the flow of violative products and to correct the conditions that caused a violation to occur. The three most common types of injunctions are the temporary restraining order, the preliminary injunction, and the permanent injunction.
The FDA may recommend a temporary restraining order when it believes that a serious violation has occurred, and the situation must be controlled, or the flow of product stopped immediately
A decree of permanent injunction may be entered at any time after the complaint is filed, either after a hearing or as a result of a negotiated settlement between the government and the defendant.
A product seizure is a judicial (court-approved) action for removing violative products from the marketplace.
After the inspection, and dependent upon the firm’s response to any 483 findings that are issued, the agency classifies the inspection with one of three statuses in the establishment inspection report (EIR):
No action indicated (NAI) means no objectionable conditions or practices were found during the inspection (or the objectionable conditions found do not justify further regulatory action).
Voluntary action indicated (VAI) means objectionable conditions or practices were found, and the firm’s response was satisfactory, so the agency is not prepared to take or recommend any administrative or regulatory action.
Official action indicated (OAI) means objectionable conditions or practices were found, and/or the firm’s response was not satisfactory, so regulatory and/or administrative actions will be recommended.
